A Study to Assess the Long-term Safety of QVA149 (ENLIGHTEN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01120717
First received: May 5, 2010
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: QVA149
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Participants With Adverse Events, Serious Adverse Events or Death [ Time Frame: 52 weeks + Follow-up (Up to Day 394) ] [ Designated as safety issue: Yes ]
    Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.


Secondary Outcome Measures:
  • Pre-dose FEV1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.

  • Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Clinically notable hematology values were: hemoglobin - male <115g/L, female <95 g/L; hematocrit - male <0.37v/v, female <0.32v/v; white cell count - <2.8 10E9/L or >16.0 10E9/L; platelets - <75 10E9/L or >700 10E9/L

  • Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Clinically notable biochemistry values were: sodium <125mmol/L or >160mmol/L; potassium <3.0mmol/L or >6.0mmol/L; BUN >9.99mmol/L; creatinine >176.8µmol/L; total protein (serum) <40g/L or >95g/L; albumin <25g/L; bilirubin (total) >34.2µmol/L; SGPT >3 x ULN; SGOT > 3 x ULN; gamma glutamyltransferase >3 x ULN; alkaline phosphatase (serum) >3 x ULN; glucose <2.78mmol/L or >9.99mmol/L

  • Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.

  • Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).


Enrollment: 339
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QVA149
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Drug: QVA149
capsules for inhalation, delivered by an SDDPI
Placebo Comparator: Placebo
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Drug: Placebo
capsules for inhalation, delivered by an SDDPI

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female adults aged ≥40 yrs
  • Smoking history of at least 10 pack years
  • Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
  • Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

  • Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular co-morbid conditions
  • Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
  • Patients in the active phase of a supervised pulmonary rehabilitation program
  • Patients contraindicated for inhaled anticholinergic agents and β2 agonists
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120717

  Hide Study Locations
Locations
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M3H 5S4
Canada, Quebec
Novartis Investigative Site
Mirabel, Quebec, Canada, J7J 2K8
Novartis Investigative Site
Québec, Quebec, Canada, G1G 3Z4
Canada
Novartis Investigative Site
Quebec, Canada, G1P 1J6
France
Novartis Investigative Site
Beuvry, France, 62660
Novartis Investigative Site
Ferolles-Attily, France, 77150
Novartis Investigative Site
Montpellier, France, 34059
Novartis Investigative Site
Nantes, France, 44000
Novartis Investigative Site
Pessac, France, 33604
Hungary
Novartis Investigative Site
Aszod, Hungary, 2170
Novartis Investigative Site
Baja, Hungary, 6500
Novartis Investigative Site
Erd, Hungary, 2030
Novartis Investigative Site
Godollo, Hungary, 2100
Novartis Investigative Site
Makó, Hungary, 6900
India
Novartis Investigative Site
New Delhi, Delhi, India, 110029
Novartis Investigative Site
Banglaore, Karnataka, India, 560027
Novartis Investigative Site
Mysore, Karnataka, India, 570004
Novartis Investigative Site
Indore, Madhya Pradesh, India, 452001
Novartis Investigative Site
Mumbai, Maharashtra, India, 400007
Novartis Investigative Site
Dehli, New Delhi, India, 110063
Novartis Investigative Site
Coimbatore, Tamil Nadu, India, 641044
Novartis Investigative Site
Chennai - Tamil Nadu, India, 600 087
Novartis Investigative Site
Mangalore, India
Korea, Republic of
Novartis Investigative Site
Koyang-si, Gyeonggi-do, Korea, Republic of, 410-773
Novartis Investigative Site
Busan, Korea, Republic of, 602-739
Novartis Investigative Site
Seoul, Korea, Republic of, 158-710
Novartis Investigative Site
Seoul, Korea, Republic of, 140-743
Latvia
Novartis Investigative Site
Riga, LV, Latvia, LV-1038
Novartis Investigative Site
Daugavpils, Latvia, LV-5401
Novartis Investigative Site
Jekabpils, Latvia, LV-5201
Novartis Investigative Site
Riga, Latvia, 1002
Lithuania
Novartis Investigative Site
Alytus, Lithuania, LT-62114
Novartis Investigative Site
Kaunas, Lithuania, 44320
Novartis Investigative Site
Klaipeda, Lithuania, 92288
Novartis Investigative Site
Klaipeda, Lithuania, LT-92231
Novartis Investigative Site
Vilnius, Lithuania, 06001
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
Romania
Novartis Investigative Site
Bucharest, District 1, Romania, 011422
Novartis Investigative Site
Bucharest, District 1, Romania, 10457
Novartis Investigative Site
Bucharest, District 3, Romania, 030303
Novartis Investigative Site
Brasov, Jud. Brasov, Romania, 500118
Novartis Investigative Site
Iasi, Jud. Iasi, Romania, 700115
South Africa
Novartis Investigative Site
Pretoria, South Africa
Novartis Investigative Site
Pretoria, South Africa, 0184
United Kingdom
Novartis Investigative Site
Bath, United Kingdom, BA2 3HT
Novartis Investigative Site
Bath, United Kingdom, BA1 2SR
Novartis Investigative Site
Cambridge, United Kingdom, CB7 5JD
Novartis Investigative Site
Chesterfield, United Kingdom, S40 4TF
Novartis Investigative Site
Glasgow, United Kingdom, G69 7AD
Novartis Investigative Site
Irvine, United Kingdom, KA12 0AY
Novartis Investigative Site
Lancashire, United Kingdom, FY3 7EN
Novartis Investigative Site
Watford, United Kingdom, WD25 0EA
Novartis Investigative Site
Wellingborough, United Kingdom, NN8 4RW
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01120717     History of Changes
Other Study ID Numbers: CQVA149A2307, 2009-013235-38
Study First Received: May 5, 2010
Results First Received: December 13, 2012
Last Updated: January 28, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: Research Ethics Medical Committee
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
India: Drugs Controller General of India
Korea: Food and Drug Administration
Korea: Institutional Review Board
Latvia: State Agency of Medicines
Latvia: Institutional Review Board
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Romania: Ministry of Public Health
Romania: National Medicines Agency
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration

Keywords provided by Novartis:
QVA149
COPD
combination bronchodilator

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014